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Neutralyze clearing serum - Medication Information

Product NDC Code 57524-015
Drug Name

Neutralyze clearing serum

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 346298
Application Number part333D
Labeler Name Kantian Skincare, LLC
Packages
Package NDC Code Description
57524-015-01 45 ml in 1 bottle (57524-015-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Salicylic acid 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions: Sensitivity test for a new user: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow these directions: cover the entire affected area with a thin layer one to three times daily. Do not rinse off. Because excessive drying or skin irritation may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor. If bothersome dryness, peeling or irritation occurs, reduce application to once a day or every other day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: WATER, ALCOHOL, DIMETHICONE, BETAINE, 1,2-HEXANEDIOL, MANDELIC ACID, POLYACRYLATE CROSSROLYMER-6,DEHYDROXANTHAN GUM, PHENOXYETHANOL, AMMONIA, T-BUTYL ALCOHOL, DENATONIUM BENZOATE, BLUE 1 (CL 42090)

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use for the treatment of acne

Purpose

Information about the drug product’s indications for use.
Purpose Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Neutralyze Clearing Serum Salicylic Acid Salicylic Acid Salicylic Acid Water Alcohol Dimethicone Betaine 1,2-hexanediol Mandelic Acid Ammonium Acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) Dehydroxanthan Gum Phenoxyethanol Ammonia Tert-Butyl Alcohol Denatonium Benzoate FD&C Blue No. 1

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel – Bottle Label. neutralyze ® NEUTRALYZE CLEARING SERUM SKIN REPAIRING ACNE TREATMENT GEL STEP 2 – REPAIR CLEARS ACNE, FADES DARK SPOTS & CORRECTS UNEVEN SKIN TONE CONTROLS OIL, UNCLOGS & REDUCES THE SIZE OF PORES 1.52 FL. OZ./45 mL Principal Display Panel – Bottle Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have very sensitive skin or are sensitive to salicylic acid.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation becomes severe.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product : skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only When using this product : skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher. Do not use if you have very sensitive skin or are sensitive to salicylic acid. Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API